GE Healthcare Recalls MRI Systems Due to Reporting Tool Error
GE Healthcare is recalling multiple MRI systems because an error in the SR Viewer Reporting Tool allows edits to be saved to incorrect reports.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or deaths. The hazard is a software reporting error without reported physical harm, fitting the Moderate category for low-risk or theoretical hazards without reported illness.
Plain-English summary
GE Healthcare, LLC is recalling specific models of magnetic resonance (MR) systems, including the Optima MR450w, Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, Signa Vibrant, and GE 1.5T Signa HDe. The recall involves 4,026 units distributed worldwide, including 1,672 units in the United States.
The recall is due to an error in the SR Viewer Reporting Tool. This defect allows users to make edits on a report and save them into incorrect reports. The source text does not report any illnesses, injuries, or deaths associated with this defect.
Healthcare facilities should contact GE Healthcare for instructions on how to address the software error. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Optima MR450w, Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, Signa Vibrant, and GE 1.5T Signa HDe MR System. The GE Signa HDx MR system is a whole body magnetic resonance scanner.
- Manufacturer
- GE Healthcare, LLC
Distribution
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